Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/ )
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Components of Participating Organizations
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov/)
Office of Research Integrity (ORI), (http://ori.hhs.gov/)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
National Library of Medicine (NLM), (http://www.nlm.nih.gov/)
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov/)
National Cancer Institute (NCI) (http://www.nci.nih.gov/)

Title: Research on Research Integrity (R01)

Announcement Type
This is a reissue of RFA-NR-06-001, which was previously released June 30, 2005

Update: The following updates relating to this announcement have been issued:

• September 28, 2007 - This RFA has been reissued as RFA-RR-07-004.
• September 28, 2007 - This RFA has been reissued as RFA-RR-07-003.
• July 5, 2006 (NOT-CA-06-031) - Notice to announce the participation of the NCI on this RFA.

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

The purpose of the proposed grant program is to foster empirical research on research integrity. The sponsoring programs are particularly interested in research that will provide clear evidence (rates of occurrence and impacts) of potential problems areas as well as societal, organizational, group, and individual factors that affect, both positively and negatively, integrity in research. Applications must have clear relevance to biomedical, behavioral health sciences, and health services research. Applicants are strongly encouraged to take into consideration problems or issues that have relevance to specific missions of DHHS, AHRQ, or NIH institutes and centers.

For the purposes of this RFA, "research" is interpreted broadly to include societal, organizational, group, and individual aspects of the enterprise. "Integrity" is understood as "the use of honest and verifiable methods in proposing, performing, and evaluating research and reporting research results with particular attention to adherence to rules, regulations, guidelines, and commonly accepted professional codes or norms."

Proposals focused on normative ethical analysis or biomedical ethics issues will not be considered. Applicants with these interests should consider applying for Research on Ethical Issues in Human Subjects Research, PA-06-367 (R03), PA-06-368 (R21), or PA-06-369 (R01).

1. Research Objectives

Integrity requires acting correctly or properly. In research, integrity requires adhering to responsible research practices or, following the definition above, "the use of honest and verifiable methods in proposing, performing, and evaluating research and reporting research results, with particular attention to adherence to rules, regulations, guidelines, and commonly accepted professional codes or norms." For additional information on this definition, and research topics, see http://ori.hhs.gov/research/potential_research_topics.shtml

While a great deal has been written about integrity in research and its importance, empirical information is lacking in four crucial areas:

• the standards that guide responsible practice, how are they set, and the extent to which researchers routinely adhere to these standards;
• the effectiveness of professional self-regulation in research;
• the factors that influence students, researchers and research institutions to adhere to or deviate from integrity in research and how these factors can be reinforced or modified to promote responsible practices; and
• the economic and intellectual impacts of behaviors that fail to adhere to rules, regulations, guidelines, and commonly accepted professional codes or norms.

This RFA seeks applications for empirical research that will provide information about these areas in ways that will aid policymaking and help promote integrity in PHS funded research. The participating programs are especially interested in quantifiable information that is relevant to particular PHS research communities and/or research interests. Projects that are relevant to the current NIH Roadmap Initiatives (New Pathways to Discovery, Research Teams of the Future, and Re-engineering the Clinical Research Enterprise) are also encouraged.

Areas of Interest

The following topics and study areas are examples and are not intended to be comprehensive or exhaustive. The areas of research detailed below are of special interest.

1. Standards for responsible conduct (best practices). The standards for responsible conduct in research are complex and not always apparent. Some are clearly described and must be followed (e.g. Federal regulations for human and animal research or for handling misconduct); others are clearly described but have no compelling authority (e.g. Federal guidelines and professional codes). While others are more customs than clearly defined standards and can vary from field to field or research setting to research setting (e.g. for designing experiments; recording, storing, interpreting and reporting data; or assigning authorship).

The participating Institutes and Agencies are interested in knowing how standards for responsible conduct in research are formulated and the practices these standards endorse or discourage. In proposing studies in this area, researchers should pay attention to and clearly distinguish ideal from actual practices. What practices are ideally recommended? What practices do researchers routinely accept and, by implication, assume are responsible? There is particular interest in knowing more about the standards for:

2. Self-regulation. Self-regulation plays a vital role in maintaining integrity in research and for ensuring the reliability of the research record. Even in areas that are subject to Federal and local regulation (e.g. misconduct policies), regulators/administrators rely heavily on the research community to follow the rules and to report problems when observed.

The participating Institutes and Agencies are interested in knowing how self-regulation operates in different research areas and its effectiveness. Studies proposed in this area should explore both ideals and real practices. What responsibilities for self-regulation do researchers recommend? Are researchers accepting their responsibilities for self-regulation? How effective is self- regulation? There is particular interest in knowing more about self- regulation as it pertains to:

3. Factors that enhance or undermine integrity. Integrity is primarily a personal responsibility, but it can be and often is influenced by other factors, such as the attitudes of mentors, colleagues, and institutional leaders; institutional priorities; the availability of different types of research funding; local, national and/or world events; cultural influences and personal obligations.

The participating Institutes and Agencies are interested in knowing which factors play primary roles in either encouraging or discouraging the adoption of high standards for integrity in research. Studies proposed in this area should not only explore what these factors are but also how they can be influenced or changed. Does education about responsible research practices make a difference, and if so what approaches to education have the most impact? Are institutional factors important and if so how can they be changed? How do different incentives (interests) promote or undermine integrity? There is particular interest in knowing more about factors that enhance integrity in relation to:

4. Economic, policy, and scientific impacts. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. Behaviors that fail to adhere to rules, regulations, guidelines, and commonly accepted professional codes or norms can compromise these goals by wasting funds and/or undermining the reliability of the research record.

The participating Institutes and Agencies are interested in knowing more about the economic, policy and scientific impacts of research misconduct and questionable research practices. Studies are encouraged that will provide realistic estimates of:

Relevant Research Perspectives and Disciplines.

Relevant research perspectives and disciplines include, but are not limited to: anthropology, applied philosophy, biomedical informatics, business, economics, education, information studies, law, organizational studies, health services, political science, psychology, public health, sociology, and survey and evaluation research, plus the physical, biomedical, and clinical sciences, including nursing. The NINR is particularly interested in research that has an impact on patient outcomes. The AHRQ is particularly interested in research done by health services researchers on these areas of interest. The NIGMS is particularly interested in research on issues involving public-private partnerships, especially those involving the basic sciences supported by this institute. The NLM is particularly interested in issues related to research integrity in the context of in-silico research, online publications, and the management and maintenance of integrated and federated data sets.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the R01 award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

2. Funds Available

The ORI intends to commit approximately $1,500,000 in FY 2007 to fund new grants in response to this RFA. The NINR, ORI, NIGMS, NINDS, NLM, AHRQ and other ICs may provide additional funding for projects relevant to their research programs. It is anticipated that 5-8 awards will be made, contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

An applicant may request a project period of up to 2 years and a budget for direct costs of up to $175,000 per year excluding Fiscal and Administrative costs (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html). Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will vary.

Applicants developing new research areas or assembling new, interdisciplinary project teams should consider proposing limited, short-term projects to establish the methods for and validity of the work they propose to do (e.g., $75,000-100,000/year for one or two years). Larger, longer-term applications should be limited to major data collection efforts that involve multiple institutions, phased surveys, detailed direct or on site analysis, or other major research work that cannot be accomplished in smaller studies.

In addition to new applications, amended applications for unfunded projects previously submitted to NIH in response to preceding RFAs from NIH/ORI will be accepted. Competitive continuations of existing projects are not eligible under this RFA.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State government
• Units of local government
• Eligible agencies of the Federal government
• Domestic Institutions
• Faith-based or community-based organizations

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing or Matching

Cost sharing not required.

3. Other-Special Eligibility Criteria

Successful applicants should plan to participate in future ORI-sponsored conferences on research on research integrity to report progress, discuss problems, and share information related to the conduct of their grants. It is therefore strongly recommended that costs associated with attendance of the principal investigator at one conference each year be included as part of the budget proposal. Applicants are also encouraged to include funds for at least one additional professional presentation of research results over the course of the grant period.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): August 14, 2006
Application Receipt Date(s): September 14, 2006
Peer Review Date(s): January-February 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s): July 2007

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

Although a letter of intent is recommended, it is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Alexis D. Bakos, Ph.D., M.P.H., R.N., Program Director
Office of Extramural Programs
National Institute of Nursing Research
One Democracy Plaza
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD 20892-4870
Phone: 301-594-2542
Fax: 301-480-8260
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.HTML)

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. Personal deliveries of applications are no longer permitted.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the ORI and NINR. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Award Criteria).

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee’s ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of program priorities

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by CSR in accordance with the review criteria stated below.

As part of the initial merit review, all applications:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique.
• Receive a second level of review by the NINR Council and other appropriate national advisory councils or boards.

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. Research on Research Integrity furthers these goals by providing fundamental information about the health of the NIH-supported research itself. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on our understanding of research NIH-supported research and the ways in which it is used to make decisions about science and health-care policy. Each of these criteria below will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance. Does this study identify and address one or more of the research objectives identified in the RFA? Will the study significantly advance these objectives? Does the study have clear relevance to biomedical, behavioral health sciences, and health services research? Does the study to take into consideration problems or issues that have relevance to specific missions of DHHS, AHRQ, or NIH institutes and centers? Will the study yield useful, empirical information?

Approach Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Are the methods clearly described? Have the researchers collected relevant preliminary information? Are surveys and other test instruments adequately described and appropriate to the study? Are survey populations appropriate for the study and clearly identified? Can the researchers gain access to the information and/or populations they are proposing to study? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation. Have the researchers fully explored prior research and explained how their work will build on or advance that research? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? Does the project employ novel concepts, approaches or methods?

Investigators. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Is all of the needed expertise (e.g. statistical analysis, survey methodology) available and well integrated into the project?

Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Are their environmental factors that could limit the success of the study, such as institutional restrictions on data gathering or institutional conflicts of interest?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and

http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

N/A

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization via electronic means. The NoA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Mary D. Scheetz, Ph.D.
Director, Extramural Research
Office of Research Integrity (ORI/DHHS)
1101 Wootton Parkway, Suite 750
Rockville, MD 20852
Phone: (240) 453-8438
Fax: (301) 443-5351
E-mail: [email protected]

Alexis D. Bakos, Ph.D., M.P.H., R.N.,
Program Director
Office of Extramural Programs
National Institute of Nursing Research (NINR/NIH)
One Democracy Plaza
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD 20892-4870
Phone: (301) 594-2542
Fax: (301) 480-8260
E-mail: [email protected]

Jean Chin, Ph.D.
Program Director
Division of Cell Biology and Biophysics (CBB)
National Institute of General Medical Sciences (NIGMS/NIH)
45 Center Drive
Bethesda, MD 20892-6200
Phone: 301-594-2485
Fax: 301-480-2004
E-Mail: [email protected]

Claudia S. Moy, Ph.D.
Program Director
National Institute of Neurological Disorders and Stroke (NINDS/NIH)
Neuroscience Center, Room 2214
6001 Executive Blvd., MSC 9520
Bethesda, MD 20892-9520
(Courier: Rockville, MD 20852)
Phone/Voice: (301) 496-2789
Fax: (301) 480-1080
E-mail: [email protected]

Valerie Florance, Ph.D.
Deputy Director
National Library of Medicine (NLM/NIH)
Office of Extramural Programs
Rockledge 1, Suite 301
6705 Rockledge Drive
Bethesda, MD 20892
Phone: 301.594.4882
Fax: 301.402.2952
E-mail: [email protected]

Sally Flanzer, PhD, CIP
Human Protections Administrator
Office of Extramural Research, Education, and Priority Populations (OEREP)
Agency for Healthcare Research and Quality (AHRQ)
US Department of Health and Human Services (DHHS)
540 Gaither Road, Room 2042
Rockville, Maryland 20850
Phone 301-427-1538
Fax 301-427-1562
E-mail: [email protected]

2. Peer Review Contacts:

Steven H. Krosnick, M.D.
SRA, Health of the Population (HOP) Integrated Review Group
Center for Scientific Review (CSR), NIH
6701 Rockledge Drive, Room 3028A, MSC 7770
Bethesda, MD 20892 (20817 for overnight mail)
Phone: 301- 435-1712
Fax: 301-480-1056
E-mail: [email protected]

3. Financial or Grants Management Contacts:

Brian Albertini
Chief, Office of Grants/Contract Management
National Institute of Nursing Research (NINR), NIH
6701 Democracy Blvd, Rm. 710
One Democracy Plaza
Bethesda, MD 20892-4870 (courier use 20817)
Phone: 301- 594-6869
Fax: 301-402-4502
E-mail: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.